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Not yet recruiting NCT06884735

Virtual Reality Exposure Therapy (VRET) in Psychomotor Disadaptation Syndrome

No phase Interventional Psychomotor Disadaptation Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: exposure to virtual reality.
Who it may be relevant to
Registry conditions: Psychomotor Disadaptation Syndrome. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Virtual Reality Exposure Therapy (VRET) for Balance in Patients Suffering From Psychomotor Disadaptation Syndrome

Overview

According to demographic projections, by 2040, a quarter of the French population will be over 65. In this age group, the quality and quantity of visual, somaesthetic and vestibular information decline. This weakening of the balancing and the recurrence of falls lead to a restriction of activities of daily living and give rise to a fear of falling. Psychomotor maladjustment syndrome (PMDS) is a serious consequence of falls. A significant retropulsion when sitting or standing, as well as hypertonia characterize the posturobehavioral component of PMDS. It coexists with a psychological component, marked by a fear of the anterior emptiness. A series of studies inducing fear and experimentally manipulating its intensity demonstrated a greater displacement of the center of pressure when subjects were exposed to elevated platforms. In addition to the subjective evaluation of fear, this emotion can be assessed by heart rate variability. Despite the existence of standards and metrics adapted to the clinical setting, only one study investigated the association between the number of falls and heart rate variability in patients with neurodegenerative disorders. In recent years, cognitive and behavioral therapies using virtual reality (TERV) have improved balance in patients with cardiovascular disease and Parkinson's disease. Virtual reality (VR) thus appears to be an interesting therapeutic approach to the treatment of psychological as well as postural-behavioral disorders of PDMS. Although the feasibility of a VR intervention has been tested in elderly people (APs) suffering from PMDS, its effect has never been evaluated.

Interventions

  • Other exposure to virtual reality
    exposure to virtual reality

Primary outcome measures

  • Balance [Time frame: Day 1]

Eligibility criteria

Inclusion criteria

  • Patients diagnosed with PMDS
  • Ability to stand without human or technical assistance
  • Falls Efficacy Scale International Short (FES-I short) > 13
  • Functional Reach Test (FRT) score < 26 cm
  • Mini-Mental State Examination (MMSE) score ≥ 20

Exclusion criteria

  • Patients with disorders that may interfere with immersion in virtual reality (e.g. cerebellar syndromes, Parkinsonian syndromes, hallucinations, sensory or neurocognitive disorders)
  • Cybermalaise or cyberkinetosis

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

France · 1 center
  • Hôpital Nord Franche-Comté — Trévenans

Identifiers

NCT: NCT06884735 · 2024-03-TERV-SDPM

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗